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What is BrainsWay Deep TMS?

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An effective treatment for depression
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If you’ve been diagnosed with major depressive disorder (MDD) and one or more antidepressant medications haven’t worked for you, BrainsWay D can help you achieve wellbeing. Deep TMS was designed to stimulate neuronal targets using its patented H-coils, resulting in a deep and broad penetration of the areas of the brain that are affected in neuropsychiatric disorders.

How effective is BrainsWay D?

In a large scale, double-blinded multicenter clinical trial, approximately 1 in 3 treatment-resistant patient achieved remission after 4 weeks.  This includes the subset of patients who had previously failed 3 or more antidepressant medications (Levkovitz Y, et al. World Psychiatry 2015; 14:64-73).  In real-life clinical settings, results have been even more substantial, with a 48% remission rate and 73% response rate.

Is BrainsWay D covered by insurance?

On the strength of its FDA clearance and clinical data, BrainsWay D is covered by Medicare and nearly all private insurance companies. Medicaid coverage varies by state.  BrainsWay offers complimentary support services to help Deep TMS providers secure insurance coverage for as many eligible patients as possible.

I have already tried other medications and had poor results – will BrainsWay D be any better?

Studies have shown the treatment to be effective for patients with depression, no matter how many medications were tried in the current depressive episode.  A recent independent clinical study demonstrated that BrainsWay Deep TMS plus standard medication was significantly more effective at reducing depression levels among Major Depressive Disorder (MDD) patients compared with standard medication alone (FilipčićIet al. (2019) Efficacy of repetitive transcranial magnetic stimulation using a figure-8-coil or an H1-Coil in treatment of major depressive disorder; A randomized clinical trial. Journal of Psychiatric Research 114: 113-119).

Has BrainsWay D been tested?

BrainsWay D uses Deep TMS technology, which has been tested in over 60 clinical studies for various indications in leading institutions worldwide. The FDA has cleared this technology for clinical use in Major Depressive Disorder and Obsessive-Compulsive Disorder.  In addition, Deep TMS is currently CE Marked for 13 neuropsychiatric conditions throughout Europe. Over 500,000 treatments have already been delivered with BrainsWay D.

How does the treatment work?

The treatment integrates seamlessly into your routine. During each session, you are comfortably seated on a chair and a cushioned helmet is placed over your head.  The helmet uses magnetic fields to stimulate the targeted brain area and improve depressive symptoms. The procedure requires daily sessions of 20 minutes for 4-6 weeks. As the treatment does not require hospitalization or anesthesia, and entails no memory loss and no systemic side effects, you can return to your normal routine after each session.

Does the treatment entail any discomfort?

BrainsWay D is a non-invasive procedure, which eliminates the need for hospitalization. Patients may experience minor side effects such as headaches or minor pain at the site of the treatment. However, this is usually brief and ceases after the first few sessions.


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      About Deep TMS for Depression                                                   How Deep TMS Can Help Patients

 

 


1Safety Information: Patients should consult with their doctor before undergoing BrainsWay D. The most common side effects include headaches and application pain or discomfort. There is also a very rare risk of seizure associated with the treatment. Patients with metal in or around the head such as in metal plates, implants and stents, should not undergo Deep TMS treatment.

2Remission Response Rates: In the multicenter trial that led to BrainsWay’s FDA clearance for MDD, 1 in 3 medication resistant patients achieved full remission and 38.4% achieved a positive response. Real life settings have shown significantly better results. Data on file

3Indication: BrainsWay D is indicated by the FDA for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder, who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. FDA 510(k) No K122288.


 

Why Get Treated With BrainsWay Deep TMS?

 

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Is BrainsWay Deep TMS Right for You?

When Should BrainsWay D Treatment be Used?

Indications for Use

BrainsWay D is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. BrainsWay Deep TMS will typically be recommended where patients have participated in psychotherapy unsuccessfully, failed to achieve sufficient improvement from one or more antidepressants, and/or been unable to tolerate the side effects of medication.  BrainsWay Deep TMS is often recommended as a more patient-friendly alternative to ECT (electroconvulsive therapy).  ECT requires general anesthesia, the induction of a brief seizure, and the potential for short-term memory loss.  BrainsWay D is an outpatient non-invasive procedure with minimal side effects that you can integrate into your normal activities.  Your mental healthcare provider will review your medical and depression history to determine if BrainsWay D treatment is appropriate for you or not.

When Should BrainsWay D Treatment Not be Used?

BrainsWay D treatment delivers a magnetic field that could cause any metal objects that are near the device to move or to get hot. The treatment should not be used if you have metal implants in or around your head, such as metal plates, implants, or stents.  Standard amalgam dental fillings are not affected by Deep TMS.  Patients should consult with their mental health professional before undergoing BrainsWay D treatment.

Important Safety Information

BrainsWay D Treatment Safety Information

Safety of BrainsWay D was demonstrated in a clinical study involving 233 patients with moderate to severe Major Depressive Disorder. The patients ranged in age from 22 to 68 years. This section summarizes the adverse events and side effects reported in the clinical study with BrainsWay D.

  • There were no deaths in patients who took part in the clinical trial
  • Systemic side effects such as weight gain, dry mouth and sexual problems were not observed.
  • Tests of memory function during treatment showed no change during the clinical trial.

You should discuss the warnings and precautions related to Brainsway D treatment with your doctor to determine if any precautions should be taken prior to or during your treatment.

 

Adverse Events

Table 1 below presents the adverse events reported in the clinical study in ≤5% or more of the patients who received the BrainsWay D treatment or the sham (placebo) treatment. Safety information is provided from all patients who were treated in the clinical study.

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Application site pain or discomfort was reported in 25% and 19% of patients who were treated with the BrainsWay D, and in less than 1% and 4.1% of the patients who received the sham (placebo) treatment. Pain in the jaw was reported in 10.2% of patients who received the BrainsWay D treatment, and in less than 1% of the patients who received the sham treatment if you feel pain or discomfort during the therapy. This indicates that these side effects are caused by the BrainsWay D treatment. You should inform the administrator of the treatment if you feel pain or discomfort during the therapy. The helmet of the BrainsWay D System may be slightly adjusted on your head to relieve the pain or discomfort. Pain and discomfort associated with treatment usually gets better or goes away altogether with successive treatments.


Headaches were reported in 47% of patients who received the treatment, and in 36% of the patients who received the sham (placebo) treatment. This indicates that headaches were not necessarily caused as a result of the BrainsWay D treatment. Headaches usually get better or go away altogether with successive treatments. Headaches may also be relieved by using common over-the-counter pain medications such as acetaminophen. Other side effects which may occur but are not necessarily caused by BrainsWay D treatment include muscle twitching, back pain, anxiety or insomnia.

 

Additional Safety & Efficacy Data